Compositions and methods for treating pancreatic enzyme deficiencies in mammals

Abstract

A composition containing enzymes, L-arginine, and other components for treating exocrine pancreatic enzyme insufficiencies and gastrointestinal disorders in mammals. The compositions replace pancreatic enzymes while concurrently treating the side effects of small intestinal bacterial overgrowth and gastrointestinal mucosal degeneration that occurs with pancreatic enzyme loss. The composition can be mixed into animal feeds or sprayed onto extruded feeds prior to consumption.

What is claimed is: 
     
       1. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base; 
 the active ingredients comprise:
 a protease; 
 a lipase; 
 an amylase; and 
 L-arginine; and 
 
 the composition is administered to the mammal in an amount and for a time effective to elicit at least one of the following effects:
 a normalization of fasting blood cobalamin levels; 
 a normalization of fasting blood folate levels; 
 a normalization of fasting blood trypsin-like immunoreactivity levels; 
 a normalization of dysbiosis index; and 
 an increase in weight. 
 
 
     
     
       2. The method of  claim 1 , wherein the composition is in a powder form, the composition is added in powder form to or mixed with food prior to the administering to thereby form a composition-supplemented food, and the administering comprises feeding the composition-supplemented food to the mammal. 
     
     
       3. The method of  claim 1 , wherein the composition is in a powder form, the composition in powder form is mixed with a liquid to thereby form a composition-supplemented liquid, the composition-supplemented liquid is added to or mixed with food prior to the administering to thereby form a composition-supplemented food, and the administering comprises feeding the composition-supplemented food to the mammal. 
     
     
       4. The method of  claim 1 , wherein the protease, the lipase, and the amylase are all microbial enzymes. 
     
     
       5. The method of  claim 1 , wherein the protease, the lipase, and the amylase are all microbially produced. 
     
     
       6. The method of  claim 1 , wherein the inert carrier base is present in the composition in an amount from about 12.5% w/w to about 50% w/w. 
     
     
       7. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base; 
 the active ingredients comprise:
 a protease; 
 a lipase; 
 an amylase; and 
 L-arginine; and 
 
 the secondary disorder of the exocrine pancreatic insufficiency comprises small intestinal bacterial overgrowth, gastroenteritis, or mucositis. 
 
     
     
       8. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base; and 
 the active ingredients comprise:
 a protease, wherein the protease is present in the composition an amount from about 200,000 USP Units/g to about 800,000 USP Units/g; 
 a lipase, wherein the lipase is present in the composition in an amount from about 35,000 USP Units/g to about 140,000 USP Units/g; 
 an amylase, wherein the amylase is present in the composition in an amount from about 230,000 USP Units/g to about 920,000 USP Units/g; and 
 L-arginine, wherein the L-arginine is present in the composition in an amount from about 2.5% w/w to about 10% w/w. 
 
 
     
     
       9. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base; 
 the active ingredients comprise:
 a protease, wherein the protease comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.4.24.28; 
 a lipase, wherein the lipase comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.1.1.3; 
 an amylase, wherein the amylase comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.2.1.1; and 
 L-arginine. 
 
 
     
     
       10. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base; and 
 the active ingredients comprise:
 a protease; 
 a lipase; 
 an amylase; 
 L-arginine; and 
 vitamin B12. 
 
 
     
     
       11. The method of  claim 10 , wherein the vitamin B12 is present in the composition in an amount of about 0.01% w/w to about 0.05% w/w. 
     
     
       12. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base, wherein the active ingredients comprise:
 a protease; 
 a lipase; 
 an amylase; 
 L-arginine; and 
 a non-heme, iron-binding glycoprotein. 
 
 
     
     
       13. The method of  claim 12 , wherein the non-heme, iron-binding glycoprotein is selected from the group consisting of ferritin, lactoferrin, transferrin, and ovotransferrin. 
     
     
       14. The method of  claim 12 , wherein the non-heme, iron-binding glycoprotein is at least partially present in apo form. 
     
     
       15. The method of  claim 12 , wherein non-heme, iron-binding glycoprotein is present in the composition in an amount from about 2.5% w/w to about 10% w/w. 
     
     
       16. A method for treating exocrine pancreatic insufficiency and a secondary gastrointestinal disorder thereof in a mammal, the method comprising administering a composition to the mammal, wherein:
 the composition comprises active ingredients in an inert carrier base; 
 the active ingredients comprise:
 a protease, wherein the protease:
 is a microbially produced enzyme; 
 is a microbial enzyme; 
 comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.4.24.28; and 
 is present in the composition an amount of about 200,000 USP Units/g to about 800,000 Units/g; 
 
 a lipase, wherein the lipase:
 is a microbially produced enzyme; 
 is a microbial enzyme; 
 an enzyme with an International Union of Biochemistry (IUB) classification of 3.1.1.3; and 
 is present in the composition in an amount of about 35,000 USP Units/g to about 140,000 USP Units/g; 
 
 an amylase, wherein the amylase:
 is a microbially produced enzyme; 
 is a microbial enzyme; 
 comprises an enzyme with an International Union of Biochemistry (IUB) classification of 3.2.1.1; and 
 is present in the composition in an amount of about 230,000 USP Units/g to about 920,000 USP Units/g; 
 
 L-arginine, wherein the L-arginine is present in the composition in an amount from about from about 2.5% w/w to about 10% w/w; 
 
 the active ingredients further comprise vitamin B12 present in the composition in an amount of about 0.01% w/w to about 0.05% w/w; 
 the active ingredients further comprise a non-heme, iron-binding glycoprotein selected from the group consisting of ferritin, lactoferrin, transferrin, and ovotransferrin at least partially present in apo form and present in the composition in an amount from about 2.5% w/w to about 10% w/w; and 
 the inert carrier base is present in the composition in an amount from about 12.5% w/w to about 50% w/w.